title: Effects of probiotics in patients with diabetes mellitus type 2: study protocol for a randomized, double-blind, placebo-controlled trial.
abstract: BACKGROUND
  Low grade chronic inflammation is observed in patients with type 2 diabetes mellitus (T2DM). Endotoxin derived from gut bacteria may act as a potent inflammatory stimulant. Probiotics, which are believed to contain health promoting live microorganisms, may influence circulating endotoxin levels. Ingestion of live probiotic cultures may alter gut microbiota in a beneficial manner to reduce inflammation; no information is available whether or not they do so in patients with T2DM. Therefore, the aim of this study is to characterize the beneficial effects of probiotics on circulating endotoxin levels and other biomarkers related to systemic low-grade inflammation in patients with T2DM.
  
  
  METHODS
  One hundred and twenty consenting adult Saudi T2DM patients (naïve or newly diagnosed and without co-morbidities) will be enrolled in this clinical trial and randomized to receive daily placebo or probiotics (Ecologic®Barrier) for 26 weeks in a double-blind manner. Inflammatory and metabolic markers will be measured and fecal samples analyzed. Measurements/samples will be obtained at baseline and after 4, 8, 12/13 and 26 weeks of treatment.
  
  
  CONCLUSIONS
  It is expected that the probiotic product will induce beneficial changes in gut microbiota, reduce the systemic inflammatory state through altering systemic endotoxin levels and, as such, reduce the systemic inflammatory response observed in T2DM subjects.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT01765517.
authors.affiliation: Biomarkers Research Program, King Saud University, Riyadh 11451, Saudi Arabia. msa85@yahoo.co.uk
authors.forename: Majed S
authors.initials: MS
authors.lastname: Alokail
authors.forename: Shaun
authors.initials: S
authors.lastname: Sabico
authors.forename: Yousef
authors.initials: Y
authors.lastname: Al-Saleh
authors.forename: Nasser M
authors.initials: NM
authors.lastname: Al-Daghri
authors.forename: Khalid M
authors.initials: KM
authors.lastname: Alkharfy
authors.forename: Paul M
authors.initials: PM
authors.lastname: Vanhoutte
authors.forename: Philip G
authors.initials: PG
authors.lastname: McTernan
mesh_terms: D001419:Bacteria / Q000254:growth & development* / Q000378:metabolism; D015415:Biomarkers / Q000097:blood; D002985:Clinical Protocols; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000175:diagnosis / Q000276:immunology / Q000382:microbiology / Q000628:therapy*; D004311:Double-Blind Method; D004731:Endotoxins / Q000097:blood; D005243:Feces / Q000737:chemistry / Q000382:microbiology; D006801:Humans; D018836:Inflammation Mediators / Q000097:blood; D007422:Intestines / Q000382:microbiology*; D019936:Probiotics / Q000009:adverse effects / Q000627:therapeutic use*; D012107:Research Design; D012529:Saudi Arabia; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D004731:Endotoxins; D018836:Inflammation Mediators